Opinion
VIEWPOINT
David Korn, MD Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts. Daniel Carlat, MD The Pew Charitable Trusts, Washington, DC.
Corresponding Author: Daniel Carlat, MD, The Pew Charitable Trusts, 901 E St NW, Washington, DC 20004 (dcarlat @pewtrusts.org).
Conflicts of Interest in Medical Education Recommendations From the Pew Task Force on Medical Conflicts of Interest Most academic medical centers (AMCs) have developed financial conflict of interest (COI) policies to govern relationshipsbetweentheirfacultyandthedrugandmedical device industries. The purpose of these policies is to prevent the prospect of personal financial gain by physiciansandstafffromadverselyaffectingthecoreAMCmissions of patient care, medical education, and research. Such policies typically regulate a wide range of activities, such as promotional speakers bureaus, industry-funded continuing medical education (CME) programs, access of sales representatives to trainees and staff, and the composition of purchasing and formulary committees. Academic medical centers began adopting such policies in the 1990s in response to evidence that pharmaceutical and device promotional practices lead to shifts in physicians’ treatment choices, favoring newer and more expensive products over existing options that are as effective and cheaper and have longer track records of safety. Evidence includes empirical studies of the influence of promotional practices1 as well as internal company correspondence discovered in whistleblower lawsuits alleging kickbacks and deceptive marketing.2 The totality of this evidence suggests that certain kinds of financial relationships between physicians and industry can undermine both the practice of objective, evidencebased medicine and the integrity and credibility of academic medicine. In 2006, Brennan and a group of academic authors published an influential paper on COIs,3 which was followed by reports in 2008 from the Association of American Medical Colleges (AAMC)4 and in 2009 from the Institute of Medicine5 recommending that all medical schools adopt stringent policies to mitigate or eliminate these potentially damaging practices. TheInstituteonMedicineasaProfession,whichmaintainsacomprehensivedatabaseofmedicalschoolCOIpolicies, reported that these policies improved substantially from2008to2011butnotedtherewasstillmuchroomfor improvement in domains such as ghostwriting, pharmaceutical samples, CME, consulting, honoraria, and speakers bureaus.6 In 2008,the American Medical Student Association (AMSA) and The Pew Charitable Trusts created a “scorecard” that has annually assigned a letter grade to medical schools based primarily on their implementation of recommendations contained in the AAMC report. According to the scorecard, the percentage of medical schools that have adopted “strong” policies (corresponding to an “A” or “B” grade) has increased from 30% in 2009 to 72% in 2013,7 which is encouraging. The scorecard has not been without its detractors and has been criticized on severalgrounds,includingthelackofpeer-revieweddocumentation of its validity and reliability, the grading of prac-
tices often not relevant to medical schools per se (such as thosepertainingtopharmaceuticalsamples),andthescoring of only written policies rather than actual practices within institutions. Of greater concern, compliance with the most thoughtful and well-crafted policies is not assured; for example, one recent survey of medical schools found that up to half of medical students and residents reported receiving gifts from pharmaceutical companies, even in schools graded highly on the AMSA scorecard.8 Nonetheless, evidence suggests that strong COI policies strictly enforced, whether measured using AMSA’s methodsorinotherways,canhaveatangibleeffectonprescriber behavior. King et al9 reported that physician graduates from medical schools with gift bans in place were less likely than control groups to prescribe newly marketed medications that had no clear advantages over those of inexpensive generic drugs of the same class. More comprehensive analyses of the prescribing patterns of medical school graduates are clearly necessary, but these data provide preliminary evidence that COI policies during education and training may help graduates resist promotional hype and encourage more rational prescribing. Both Brennan et al3 and the AAMC4 recognized they were calling for a profound cultural change in the medical profession that had to begin with medical schools and teaching hospitals. To assist AMCs in deciding on best practices, in 2012 The Pew Charitable Trusts convened a task force to review the literature on COI policies and to make additional recommendations based on this work. Members included leadership from 7 AMCs in diverse geographic areas (University of Michigan Medical School, Stanford University School of Medicine, Harvard Medical School, Cleveland Clinic, University of Pittsburgh School of Medicine, UMass Memorial Healthcare, and Kaiser Permanente) as well as representatives of consumer and physician associations, AMSA, and AAMC. The task force generated recommendations in 15 domains of COI policies (Table). The full task force report is available online.10 The guiding principle was to balance appropriate boundaries in physician-industry relationships with the need to encourage collaborations crucial for improving medical care and practice. In some cases, such as prohibitions on industry-funded gifts and on attendance at industry promotional events, the recommendations are similar to those of the AAMC; in other cases, they are more restrictive.Forexample,currentAAMCpolicyrecommends that pharmaceutical sales representatives be allowed on site by appointment only and provided they are restricted from entering patient care areas. The task force, struck by the consistency of studies showing that pharmaceutical sale visits yield increased prescriptions of the sponsoring
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JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/15/2015
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Opinion Viewpoint
Table. Recommended Best Practices in Conflict of Interest (COI) Policies COI Domain Conflict of interest disclosure Industry-funded speaking relationships Industry support of accredited CME Attendance of unaccredited industrysponsored educational events Access of pharmaceutical sales representatives to AMCs Access of medical device representatives to AMCs COI curriculum Extension of AMC COI policies to community teaching affiliates Gifts and meals(including CME-related and non–CME-related meals) Consulting and advising relationships
Best Practices Required for institutions, colleagues, trainees, and patients Prohibiteda Permitted in rare circumstances with safeguards in placea Prohibited Prohibiteda,b Permitted for technical assistance with already purchased devices Required Required Prohibiteda
Marketing
Prohibiteda
Scientific activities
Permitteda
Pharmaceutical samples Pharmacy and therapeutics committee
Permitted only if mechanisms in place to prevent use for marketinga,c Disclosure and recusal requireda
Ghostwriting and honorary authorship
Prohibited
Industry-supported fellowships
Prohibited for clinical training; permitted for research traininga
Abbreviations: AMC, academic medical center; CME, continuing medical education. a
These recommendations are more stringent or more encompassing than Association of American Medical Colleges recommendations.
b
In contrast, interaction with non-sales pharmaceutical scientists is encouraged.
c
For example, samples provided only via central pharmacies.
company’s drugs even when such use is not evidence-based, recommended that AMCs ban pharmaceutical sales representatives from ARTICLE INFORMATION Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Carlat reported ownership interest in Carlat Publishing LLC but has no business involvement and has received no compensation from the company during his work with The Pew Charitable Trusts. Dr Korn reported no disclosures. Funding/Support: This work was supported by an honorarium (Dr Korn) and salary support (Dr Carlat) from The Pew Charitable Trusts and the Oregon Attorney General Consumer and Prescriber Education Grant Program. Role of the Sponsors: The funding organizations had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication. Additional Contributions: The best practice recommendations discussed in this paper were generated by the following members of the Expert Task Force on Medical Conflicts of Interest (in addition to the authors): Barbara Barnes, MD (University of Pittsburgh School of Medicine), Guy Chisolm, PhD (Cleveland Clinic), Marcia Hams, MA (Community Catalyst), Sharon Levine, MD (Kaiser Permanente, The Permanente Medical Group Inc), Philip Pizzo, MD (Stanford University School of Medicine), Reshma Ramachandran (American Medical Student Association), John Randolph, JD
2398
their facilities, while encouraging interactions between faculty and industry research scientists. Similarly, existing guidelines on industry funding of CME are permissive, recommending that a central CME office disburse funds and that courses be audited to assess compliance withAccreditationCouncilforContinuingMedicalEducationguidelines. Thetaskforce,findingevidencethatcommerciallyfundedCMEunduly influences the choice of topics offered, recommended that such funding be limited to specialized training, such as in the use of new medical devices for which expertise may be very limited and costs of training high. The task force also recommended that COI policies applicable to AMCs should apply to all training sites, such as affiliated hospitals and clinics. For students and residents to be prohibited from receivingindustrygiftsattheirprimaryteachinghospital,onlytorotateacross town and enjoy industry-funded lunches at a family practice clinic, clearly defeats a primary purpose of these policies, which is to discourage trainees from assuming that industry gifts are “business as usual” in the practice of medicine. The 2014 AMSA scorecard has been revised and expanded in light of these and other recommendations7 and will be the primary evaluation tool in the first efforts to systematically assess the COI policies of medical schools and their major teaching affiliates— more than 550 institutions in the United States. Such efforts are especially timely, given the recent implementation of the Physician Payments Sunshine Act. Drug and device companies have begun collecting data on their payments to physicians and teaching hospitals, and the first transparency reports will be published on a public website in September 2014. Effectively implementing strong, well-enforced COI policies at AMCs is critical to ensure that academic medicine can continue to engage in principled partnerships with industry, while protecting the integrity of medical education and practice.
(UMass Memorial Health Care), Jean Silver-Isenstadt, MD, PhD (National Physicians Alliance), and James Woolliscroft, MD (University of Michigan Medical School). Heather Pierce, JD, MPH, represented the Association of American Medical Colleges for assistance in providing context; however, the AAMC has not formally endorsed the Task Force’s recommendations. We also wish to thank the following individuals for their contributions, both of whom are employed by The Pew Charitable Trusts: Allan Coukell, BScPharm, for his review of the manuscript, and Sallyann Bergh, MPA, for editing and writing assistance. Mr Coukell received salary support from The Pew Charitable Trusts, and Ms Bergh receives salary support from both The Pew Charitable Trusts and the Grant program. REFERENCES 1. Spurling GK, Mansfield PR, Montgomery BD, et al. Information from pharmaceutical companies and the quality, quantity, and cost of physicians’ prescribing. PLoS Med. 2010;7(10):e1000352. 2. Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145(4):284-293. 3. Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest. JAMA. 2006;295(4):429-433.
4. Association of American Medical Colleges (AAMC). Industry Funding of Medical Education. Washington, DC: AAMC; 2008. 5. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: Institute of Medicine; 2009. 6. Chimonas S, Evarts SD, Littlehale SK, Rothman DJ. Managing conflicts of interest in clinical care. Acad Med. 2013;88(10):1464-1470. 7. American Medical Student Association (AMSA). AMSA Pharmfree Scorecard. AMSA website. http://www.amsa.org/AMSA/Homepage /TakeAction/PharmFree/ScorecardGuidelines.aspx. 2013. Accessed August 13, 2013. 8. Austad KE, Avorn J, Franklin JM, et al. Changing interactions between physician trainees and the pharmaceutical industry. J Gen Intern Med. 2013;28(8):1064-1071. 9. King M, Essick C, Bearman P, Ross JS. Medical school gift restriction policies and physician prescribing of newly marketed psychotropic medications: difference-in-differences analysis. BMJ. 2013;346:f264. 10. The Pew Charitable Trusts. Conflict-of-Interest Policies for Academic Medical Centers: Recommendations for Best Practices. The Pew Charitable Trusts website. http://www.pewhealth .org/COIBestPractices. 2013.
JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/15/2015
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VIEWPOINT
David Korn, MD Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts. Daniel Carlat, MD The Pew Charitable Trusts, Washington, DC.
Corresponding Author: Daniel Carlat, MD, The Pew Charitable Trusts, 901 E St NW, Washington, DC 20004 (dcarlat @pewtrusts.org).
Conflicts of Interest in Medical Education Recommendations From the Pew Task Force on Medical Conflicts of Interest Most academic medical centers (AMCs) have developed financial conflict of interest (COI) policies to govern relationshipsbetweentheirfacultyandthedrugandmedical device industries. The purpose of these policies is to prevent the prospect of personal financial gain by physiciansandstafffromadverselyaffectingthecoreAMCmissions of patient care, medical education, and research. Such policies typically regulate a wide range of activities, such as promotional speakers bureaus, industry-funded continuing medical education (CME) programs, access of sales representatives to trainees and staff, and the composition of purchasing and formulary committees. Academic medical centers began adopting such policies in the 1990s in response to evidence that pharmaceutical and device promotional practices lead to shifts in physicians’ treatment choices, favoring newer and more expensive products over existing options that are as effective and cheaper and have longer track records of safety. Evidence includes empirical studies of the influence of promotional practices1 as well as internal company correspondence discovered in whistleblower lawsuits alleging kickbacks and deceptive marketing.2 The totality of this evidence suggests that certain kinds of financial relationships between physicians and industry can undermine both the practice of objective, evidencebased medicine and the integrity and credibility of academic medicine. In 2006, Brennan and a group of academic authors published an influential paper on COIs,3 which was followed by reports in 2008 from the Association of American Medical Colleges (AAMC)4 and in 2009 from the Institute of Medicine5 recommending that all medical schools adopt stringent policies to mitigate or eliminate these potentially damaging practices. TheInstituteonMedicineasaProfession,whichmaintainsacomprehensivedatabaseofmedicalschoolCOIpolicies, reported that these policies improved substantially from2008to2011butnotedtherewasstillmuchroomfor improvement in domains such as ghostwriting, pharmaceutical samples, CME, consulting, honoraria, and speakers bureaus.6 In 2008,the American Medical Student Association (AMSA) and The Pew Charitable Trusts created a “scorecard” that has annually assigned a letter grade to medical schools based primarily on their implementation of recommendations contained in the AAMC report. According to the scorecard, the percentage of medical schools that have adopted “strong” policies (corresponding to an “A” or “B” grade) has increased from 30% in 2009 to 72% in 2013,7 which is encouraging. The scorecard has not been without its detractors and has been criticized on severalgrounds,includingthelackofpeer-revieweddocumentation of its validity and reliability, the grading of prac-
tices often not relevant to medical schools per se (such as thosepertainingtopharmaceuticalsamples),andthescoring of only written policies rather than actual practices within institutions. Of greater concern, compliance with the most thoughtful and well-crafted policies is not assured; for example, one recent survey of medical schools found that up to half of medical students and residents reported receiving gifts from pharmaceutical companies, even in schools graded highly on the AMSA scorecard.8 Nonetheless, evidence suggests that strong COI policies strictly enforced, whether measured using AMSA’s methodsorinotherways,canhaveatangibleeffectonprescriber behavior. King et al9 reported that physician graduates from medical schools with gift bans in place were less likely than control groups to prescribe newly marketed medications that had no clear advantages over those of inexpensive generic drugs of the same class. More comprehensive analyses of the prescribing patterns of medical school graduates are clearly necessary, but these data provide preliminary evidence that COI policies during education and training may help graduates resist promotional hype and encourage more rational prescribing. Both Brennan et al3 and the AAMC4 recognized they were calling for a profound cultural change in the medical profession that had to begin with medical schools and teaching hospitals. To assist AMCs in deciding on best practices, in 2012 The Pew Charitable Trusts convened a task force to review the literature on COI policies and to make additional recommendations based on this work. Members included leadership from 7 AMCs in diverse geographic areas (University of Michigan Medical School, Stanford University School of Medicine, Harvard Medical School, Cleveland Clinic, University of Pittsburgh School of Medicine, UMass Memorial Healthcare, and Kaiser Permanente) as well as representatives of consumer and physician associations, AMSA, and AAMC. The task force generated recommendations in 15 domains of COI policies (Table). The full task force report is available online.10 The guiding principle was to balance appropriate boundaries in physician-industry relationships with the need to encourage collaborations crucial for improving medical care and practice. In some cases, such as prohibitions on industry-funded gifts and on attendance at industry promotional events, the recommendations are similar to those of the AAMC; in other cases, they are more restrictive.Forexample,currentAAMCpolicyrecommends that pharmaceutical sales representatives be allowed on site by appointment only and provided they are restricted from entering patient care areas. The task force, struck by the consistency of studies showing that pharmaceutical sale visits yield increased prescriptions of the sponsoring
jama.com
JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/15/2015
2397
Opinion Viewpoint
Table. Recommended Best Practices in Conflict of Interest (COI) Policies COI Domain Conflict of interest disclosure Industry-funded speaking relationships Industry support of accredited CME Attendance of unaccredited industrysponsored educational events Access of pharmaceutical sales representatives to AMCs Access of medical device representatives to AMCs COI curriculum Extension of AMC COI policies to community teaching affiliates Gifts and meals(including CME-related and non–CME-related meals) Consulting and advising relationships
Best Practices Required for institutions, colleagues, trainees, and patients Prohibiteda Permitted in rare circumstances with safeguards in placea Prohibited Prohibiteda,b Permitted for technical assistance with already purchased devices Required Required Prohibiteda
Marketing
Prohibiteda
Scientific activities
Permitteda
Pharmaceutical samples Pharmacy and therapeutics committee
Permitted only if mechanisms in place to prevent use for marketinga,c Disclosure and recusal requireda
Ghostwriting and honorary authorship
Prohibited
Industry-supported fellowships
Prohibited for clinical training; permitted for research traininga
Abbreviations: AMC, academic medical center; CME, continuing medical education. a
These recommendations are more stringent or more encompassing than Association of American Medical Colleges recommendations.
b
In contrast, interaction with non-sales pharmaceutical scientists is encouraged.
c
For example, samples provided only via central pharmacies.
company’s drugs even when such use is not evidence-based, recommended that AMCs ban pharmaceutical sales representatives from ARTICLE INFORMATION Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Carlat reported ownership interest in Carlat Publishing LLC but has no business involvement and has received no compensation from the company during his work with The Pew Charitable Trusts. Dr Korn reported no disclosures. Funding/Support: This work was supported by an honorarium (Dr Korn) and salary support (Dr Carlat) from The Pew Charitable Trusts and the Oregon Attorney General Consumer and Prescriber Education Grant Program. Role of the Sponsors: The funding organizations had no role in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication. Additional Contributions: The best practice recommendations discussed in this paper were generated by the following members of the Expert Task Force on Medical Conflicts of Interest (in addition to the authors): Barbara Barnes, MD (University of Pittsburgh School of Medicine), Guy Chisolm, PhD (Cleveland Clinic), Marcia Hams, MA (Community Catalyst), Sharon Levine, MD (Kaiser Permanente, The Permanente Medical Group Inc), Philip Pizzo, MD (Stanford University School of Medicine), Reshma Ramachandran (American Medical Student Association), John Randolph, JD
2398
their facilities, while encouraging interactions between faculty and industry research scientists. Similarly, existing guidelines on industry funding of CME are permissive, recommending that a central CME office disburse funds and that courses be audited to assess compliance withAccreditationCouncilforContinuingMedicalEducationguidelines. Thetaskforce,findingevidencethatcommerciallyfundedCMEunduly influences the choice of topics offered, recommended that such funding be limited to specialized training, such as in the use of new medical devices for which expertise may be very limited and costs of training high. The task force also recommended that COI policies applicable to AMCs should apply to all training sites, such as affiliated hospitals and clinics. For students and residents to be prohibited from receivingindustrygiftsattheirprimaryteachinghospital,onlytorotateacross town and enjoy industry-funded lunches at a family practice clinic, clearly defeats a primary purpose of these policies, which is to discourage trainees from assuming that industry gifts are “business as usual” in the practice of medicine. The 2014 AMSA scorecard has been revised and expanded in light of these and other recommendations7 and will be the primary evaluation tool in the first efforts to systematically assess the COI policies of medical schools and their major teaching affiliates— more than 550 institutions in the United States. Such efforts are especially timely, given the recent implementation of the Physician Payments Sunshine Act. Drug and device companies have begun collecting data on their payments to physicians and teaching hospitals, and the first transparency reports will be published on a public website in September 2014. Effectively implementing strong, well-enforced COI policies at AMCs is critical to ensure that academic medicine can continue to engage in principled partnerships with industry, while protecting the integrity of medical education and practice.
(UMass Memorial Health Care), Jean Silver-Isenstadt, MD, PhD (National Physicians Alliance), and James Woolliscroft, MD (University of Michigan Medical School). Heather Pierce, JD, MPH, represented the Association of American Medical Colleges for assistance in providing context; however, the AAMC has not formally endorsed the Task Force’s recommendations. We also wish to thank the following individuals for their contributions, both of whom are employed by The Pew Charitable Trusts: Allan Coukell, BScPharm, for his review of the manuscript, and Sallyann Bergh, MPA, for editing and writing assistance. Mr Coukell received salary support from The Pew Charitable Trusts, and Ms Bergh receives salary support from both The Pew Charitable Trusts and the Grant program. REFERENCES 1. Spurling GK, Mansfield PR, Montgomery BD, et al. Information from pharmaceutical companies and the quality, quantity, and cost of physicians’ prescribing. PLoS Med. 2010;7(10):e1000352. 2. Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative review: the promotion of gabapentin: an analysis of internal industry documents. Ann Intern Med. 2006;145(4):284-293. 3. Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest. JAMA. 2006;295(4):429-433.
4. Association of American Medical Colleges (AAMC). Industry Funding of Medical Education. Washington, DC: AAMC; 2008. 5. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: Institute of Medicine; 2009. 6. Chimonas S, Evarts SD, Littlehale SK, Rothman DJ. Managing conflicts of interest in clinical care. Acad Med. 2013;88(10):1464-1470. 7. American Medical Student Association (AMSA). AMSA Pharmfree Scorecard. AMSA website. http://www.amsa.org/AMSA/Homepage /TakeAction/PharmFree/ScorecardGuidelines.aspx. 2013. Accessed August 13, 2013. 8. Austad KE, Avorn J, Franklin JM, et al. Changing interactions between physician trainees and the pharmaceutical industry. J Gen Intern Med. 2013;28(8):1064-1071. 9. King M, Essick C, Bearman P, Ross JS. Medical school gift restriction policies and physician prescribing of newly marketed psychotropic medications: difference-in-differences analysis. BMJ. 2013;346:f264. 10. The Pew Charitable Trusts. Conflict-of-Interest Policies for Academic Medical Centers: Recommendations for Best Practices. The Pew Charitable Trusts website. http://www.pewhealth .org/COIBestPractices. 2013.
JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a University of St. Andrews Library User on 05/15/2015
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